NARMS Scientific Meeting

1. NARMS Scientific Meeting Patrick McDermott, MS, PhD Director, National Antimicrobial Resistance Monitoring System U.S. Food & Drug Administration 20 July 2011, St. Louis MO

2. Antimicrobial Use in Agriculture:Assessing the Risk FDA-CVM has a multi-pronged approach that includes: Revised safety assessment process (GFI #152) Enhanced surveillance activities (NARMS) Expanded research activities International coordination activities Education/outreach activities • How does the use of antimicrobials in food animal production affect resistance among foodborne pathogens and commensals? • What is the impact on public health?

3. GFI 152 Qualitative Risk Assessment:Components and Procedures

4. NARMS Goals • Monitor trends in antimicrobial resistance among foodborne bacteria from humans, retail meats and animals • Disseminate timely information on antimicrobial resistance to promote interventions that reduce resistance among foodborne bacteria • Conduct research to better understand the emergence, persistence, and spread of antimicrobial resistance • Assist the FDA in making decisions related to the approval of safe and effective antimicrobial drugs for animals

5. FDA Science Board Review – March 2007 Data Mgmt,Sampling, Research, International • Commitment and dedication of NARMS team is laudable. Outstanding progress and acceptance over last decade such that NARMS has evolved into a mission-critical tool for FDA • Need to keep focus on public health impact • Suggest the program should evolve and become more predictive, responsive, and expansive • Suggest visioning, strategic, and business planning processes be adopted • Endorses development of a 10-year plan with public involvement • Drafted Five-Year Strategic Plan published 2011

6. Science BoardKey Findings: Sampling • Current sampling strategies all found to have degrees of bias • Need to critically re-evaluate the sampling approach to assure data can withstand scientific, legal, and regulatory scrutiny and challenges • Need to transition to national, random sampling strategies • When not feasible, data should be stratified, or sampling should be limited and focused on specific hypothesis-driven research • Where biases cannot be corrected, the methodology should be designed as an early warning system for emerging resistance

7. Science Board Comments on Animal Sampling Slaughter Isolates: • Sampling needs to be nationally representative • Sampling biases occur as processing plants are not randomly selected • USDA encouraged to assess HACCP sampling to see if modifications can make the sample more representative • Alternatively, consider an ongoing “baseline” sampling scheme

8. Science Board Comments on Animal Sampling On-Farm Isolates: • On-farm data are essential in understanding movement of resistance from farm to fork • NAHMS data are potentially useful, but samples fail to provide a true national sample • May be best to limit on-farm sampling to specific hypothesis- driven research studies Diagnostic Lab Isolates: • Have the greatest biases and should be limited to use as an early warning system

9. Animal Component: Source of Salmonella Isolates *Carcass rinsates (chicken), carcass swabs (turkey, cattle, and swine), and ground products (chicken, turkey, and beef) collected at federally inspected slaughter and processing plants

10. Animal Component: Source of Campylobacter, Enterococcus, and E. coli Isolates *Since 2001

11. Science Board Comments on Retail Meat Sampling • Retail meat sample size is relatively small and the lack of national sampling strategy limits broader interpretation • May be more useful to adjust sampling strategy to help answer specific, hypothesis-driven research questions (e.g., sources and risk factors for resistance)

12. NARMS Strategic Plan2011-2015

13. Strategic Goals • Goal 1: To develop, implement and optimize a shared database, with advanced data acquisition and reporting tools • Goal 2: To make sampling more representative and more applicable to trend analysis • Goal 3: To strengthen collaborative research projects to address high risk food safety issues • Goal 4: To support international activities which promote food safety, and mitigate the spread of antimicrobial resistance

14. Strategic Goal 2 To make sampling more representative and more applicable to trend analysis • Objective 2.1: To increase geographic representativeness and total number of retail meat by increasing the number states participating in this program, and by increasing the number of samples tested • Objective 2.2: To modify animal sampling to overcome the biases resulting from the current reliance on FSIS HACCP compliance sampling, which is risk based and post-processing • Objective 2.3: To expand geographic representativeness of human Campylobacter sampling • Objective 2.4: To build a NARMS component for ongoing monitoring of bacteria from animal feeds • Objective 2.5: To establish systematic, representative monitoring of human commensal bacteria

15. Method Meeting: Sep 10-12, 2008. Athens GA • Revised NARMS Goals • Sample and isolate processing • Established research working groups (Lab, Epi, Mol.) • Serotyping and species identification • QC organisms and susceptibility testing • Criteria for repeat testing • PFGE updates • Microarray and Luminex • ARIS vs. manual AST for Enterococcus • Other laboratory methods issues • Developed a laboratory methods manual

16. Methods Meeting: Aug 5-7, 2009. Rockville MD • NARMS integrated database and analytical tools • Linking NARMS and PulseNet • NARMS Working Group breakouts • Sampling • Strategic Planning

17. Planning Meeting: July 15-16, 2010 Atlanta GA • International • WHO, EFSA, OIE, PAHO, PHAC, Korean, China, Denmark, Africa, IFAH • Research • Molecular biology of resistance • Genomic typing tools

18. Why We Are Here • Animal Sampling Bias • The move to risk-based sampling by FSIS necessitates a new animal sampling plan • Sampling strategy should represent food production and consumption within a region • Due to variables associated with on farm, transport, lairage and processing, different information will be obtained at different points along the food production chain • On farm sampling is most representative of the prevalence of resistance in animals where antimicrobials are used • Possibility to acquire antimicrobial use information • Denominators by commodity • Retail meat sampling is closest to the consumer and reflects in part strain types persisting in the abattoir, as well as the influence of decontamination interventions in plant that can impact resistance estimates. • National meat production is extensively integrated and distribution is broadly deployed • Increasing number of isolates to detect changes in low prevalence phenotypes may be more important than geographical diversity

19. Summary of Major ActivitiesSince the SB Review • Revised NARMS goals • Sample and isolate processing • Collaborative research • Established research working groups • NARMS integrated database and analytical tools • International harmonization • Sampling

20. NARMS Funding Dollars in Millions * includes support for FoodNet states ** includes supplies for susceptibility testing

21. Supplemental NARMS Funding - FY2011 CDC • Expand Outbreak Isolate Testing. CDC will expand antimicrobial susceptibility testing of isolates from Salmonella outbreaks. This additional testing will allow CDC to more fully use the rich epidemiologic data that is typically available from outbreak investigations. • Link Foodborne Disease Surveillance Data. Link NARMS data with information in other surveillance systems (e.g., FoodNet, PulseNet). Currently, this type of linking is very labor-intensive and it must be redone whenever up-to-date information is needed. USDA • Four on-farm pilot studies: dairy cattle, beef cattle, broilers and turkeys. These data will be supplemented by the current swine farm study ongoing at USDA-ARS Athens. Will include surveys to assess antibiotic use in sampled animals. FDA • Add retail testing sites in 2012. • To expand the number of samples collected, and therefore the ability to determine trends in different strain subtypes, the FDA is in the process of identifying candidate sites • Database development

22. Agenda Overview 8:30-9:00USDA Slaughter Sampling Emilio Esteban, Food Safety Inspection Service, (USDA) 9:00-9:30USDA On-Farm Sampling Paula Fedorka-Cray, Agricultural Research Service 9:30-10:00FDA Retail Sampling Emily Tong, (FDA) 10:00-10:15 Break 10:15-10:45 Evolution of CIPARS Retail and Food Animal Sampling Lucie Dutil, (CIPARS) 10:45-11:15 Sampling Methods Used by EFSA Pierre-Alexander Beloeil, EFSA 11:15-11:45Pitfalls of Sampling Morgan Scott, Kansas State University 11:45-1:00 Lunch On Your Own 1:00-2:00 Panel Discussion: Improving NARMS Sampling 2:00-2:10The Beef Industry Elizabeth Parker, National Cattlemen’s Beef Assocation 2:10-2:20The Swine Industry Paul Sundberg, National Pork Board 2:20-2:30The Chicken Industry Submitted 2:30-2:40The Turkey Industry Andrew Bailey, National Turkey Federation 2:40-3:40Public Comment Period 3:40-4:30Focused Discussion Moderator: Heather Tate, FDA 4:30-5:00Final Comments and Adjournment

23. Housekeeping • Breaks – Refreshments are available in the morning and at breaks. Lunch is on your own. • The meeting is being recorded and transcribed. FDA will prepare a meeting transcript and make it available on the agency’s Web site ~30 business days after the meeting. • Docket is open for comments 30 days after the meeting

24. Acknowledgements • Heather Tate - NARMS Coordinator • Katherine Bond - FDA Office of International Program • Aleta Sindelar- FDA Center for Veterinary Medicine • Kelly Covington - FDA Center for Veterinary Medicine • Alicia Corbin –Seamon Corp